Download TARGET-CONTROLLED INFUSION ANESTHESIA WITH PROPOFOL AND REMIFENTANIL COMPARED WITH MANUALLY CONTROLLED INFUSION ANESTHESIA

TARGET-CONTROLLED INFUSION ANESTHESIA
WITH PROPOFOL AND REMIFENTANIL
COMPARED WITH MANUALLY
CONTROLLED INFUSION ANESTHESIA
IN MASTOIDECTOMY SURGERIES
Naser Yeganeh*, Bahman Roshani*,
Mitra Yari* and Afshin Almasi**
Abstract
Target-controlled infusion (TCI) system is increasingly used in anesthesia to control
the concentration of selected drugs in the plasma or at the site of drug effect (effect-site). The
performance of propofol TCI delivery when combined with remifentanil in patients undergoing
elective surgeries has been investigated. Our aim in this study was to assess the anesthesia profile
of the propofol and remifentanil target controlled infusion (TCI) anesthesia as compared to the
manually controlled infusion (MCI), in mastoidectomy surgery, where a bloodless field is of utmost
importance to the surgeon. Sixty patients, aged 18-60 years ASA I-II enrolled in the study, were
divided into two equal groups. Group MCI received propofol and remifentanil by conventionaldose-weight infusion method, and Group TCI received propofol 4 µg/ml and remifentanil 4 ng/ml
as effect-site target concentration. The hemodynamic variability, recovery profile, postoperative
nausea and vomiting (PONV), surgeons satisfaction were assessed. Results were analyzed by SPSS
version 11.5. The two groups were comparable with respect to age, ASA class, sex, weight, basal
vital signs, operation time. The blood pressure and pulse were above desired levels in some data
points in the MCI Group (P ≤ 0.05). The PACU stay time to reach Aldret score of 10 was longer
in the MCI Group (42.54 ± 8 vs 59.01 ± 6 min) (P ≤ 0.05). The PONV was more common in the
MCI Group (P ≤ 0.05). Surgeon’s satisfaction of the surgical field showed no significant differences
except when described as “good”, more common in the TCI Group. TCI is capable to induce and
maintain anesthesia as well as MCI. In some stages of anesthesia, the TCI control of vital signs are
better than the MCI. In some stages of anesthesia, the TCI control of vital signs are beter than the
MCI. Recovery profile and complication rate and surgeon’s satisfactions are more acceptable in the
TCI than in the MCI. Group.
Keywords: Target-controlled infusion anesthesia, manually controlled infusion anesthesia,
remifentanil, propofol, mastoidectomy.
* MD, Associate professor of anesthesia, Department of Anesthesiology and Intensive Care, Imam Khomeini Hospital,
Kermanshah University of Medical Sciences, Iran.
** Assistant professor of anesthesia.
***MSc, Master of Science in Biostatistics, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Corresponding Author: Deputy of Education and Research in Imam Reza Hospital, Kermanshah University of Medical
Sciences, Kermanshah, Iran. Tel: +98 9121459654, Fax: +98 831 427 6355, E-mail: [email protected].
785
M.E.J. ANESTH 20 (6), 2010
786
Introduction
Target controlled infusion (TCI) is increasingly
used in anesthesia. This method of infusion of
intravenous anesthetic drugs has been investigated
for its ability to achieve targeted blood or effect site
concentrations for selected drugs. Maintaining a
constant plasma or effect compartment concentration
of an IV anesthetic requires continuous adjustment
of the infusion rate according to the pharmacokinetic
properties of the drugs which can be achieved by
commercially available target controlled infusion
pumps. The main advantage of this infusion
method among the other advantages is prompt
response to signs of inappropriate anesthesia depth
without any need to mathematical calculations for
anesthesiologists1.
Total intravenous anesthesia based on the
administration of propofol combined with an opioid,
has become a popular anesthesia technique. It allows
independent modulation of the different components
of anesthesia: unconsciousness, amnesia and loss of
response, to noxious stimuli the first two components
are controlled by hypnotics and the third by opioids.
Remifentanil appears to be an ideal analgesic for
total IV anesthesia (TIVA) in combination with
propofol, because of its independent pathway from
that of propofol as well as its rapid elimination
and favorable controllability. The performance of
propofol TCI delivery when combined with opioid
in patients undergoing elective surgery has been
investigated2-4.
In the TCI system of delivery, the
anesthesiologist, depending on the appearance of
noxious stimuli, can adjust the target concentrations
of propofol or remifentanil and change the infusion
rate. Surgeons performing mastoidectomies as well
as other otolaryngological procedures when working
microscopically under high power visual field, request
asanguinous surgical field. Decrease of bleeding could
be accomplished by targeting higher plasma or effect
site concentration of hypnotic and opioid by the TCI
system. In contradistinction, the changes in infusion
rates in the manually controlled infusion (MCI), could
be difficult, inaccurate and time consuming.
Our aim in this study was to assess the clinical
effects of propofol and remifentanil target controlled
N. Yeganeh et al
infusion (TCI) and compare them to the manually
controlled infusion (MCI), in mastoid or similar
surgeries.
Results
There were no statistical difference between the
two groups regarding ASA class, age, sex, weight,
basal vital signs and surgery duration (Table 1). Two
anesthesiologists performed 60 anesthesias and 6
surgeons performed the surgery.
Table 1
Patient demographics and characteristics
(Mean and SD in parenthesis)
MCI
TCI
(n=30)
(n=30)
*P
Value
Sex (M/F)
18/12
17/13
0.55
Age (Y)
28.03
(9.79)
26.67 (8.73)
0.57
Weight (kg)
62.00
(9.70)
63.33
(12.90)
0.34
BMI (kg/m2)
23.65
(2.52)
23.50 (3.85)
0.66
BSA (m2)
1.58 (0.15)
1.65 (0.18)
0.054
ASA (I-II)
19 / 11
17 / 13
0.081
Surgery duration(min)
73.60
(17.66)
81.67
(19.63)
0.08
Baseline Systolic
BP(mmHg)
125.13
(8.72)
121.27
(10.55)
0.67
Baseline Diastolic
BP(mmHg)
79.37
(6.39)
79.67 (8.08)
0.69
Baseline Mean
BP(mmHg)
86.60
(6.44)
84.50 (7.59)
0.98
Baseline Mean HR
(Beats/min)
76.20
(8.32)
79.12 (7.61)
0.74
* P value < 0.05 is significant.
The systolic and mean arterial pressure at T4 and
systolic arterial pressure at T5 data points were higher
in the MCI group (P value ≤ 0.05) and no statistical
differences were remarkable in the other data points
(Fig. 1). There were also no statistical difference in
heart rates in data points (Fig. 2).
The least BIS value recorded in data points were
significantly lower in T4 and T5 data points in the MCI
group (Fig. 3).
TARGET-CONTROLLED INFUSION ANESTHESIA WITH PROPOFOL AND REMIFENTANIL COMPARED WITH
MANUALLY CONTROLLED INFUSION ANESTHESIA IN MASTOIDECTOMY SURGERIES
Fig. 1
Systolic, Mean and Diastolic arterial pressure in different data
points in two groups (Mean±SD)
787
Fig. 2
Heart rate during different data points
in two groups (Mean ± SD)
110
180
170
100
150
140
130
TCI
MCI
120
110
100
Heart rate (per min)
Systolic Blood Pressure(mmHg)
160
90
90
TCI
MCI
80
70
60
80
70
50
60
T1
T2
T3
T4*
T5*
T6
T1
T7
T2
T3
T4*
T5*
T6
T7
Data points
Data points
*Significant difference between two groups
Fig. 3
BIS changes during different data points in two groups
(Mean±SD).
90
80
100
TCI
MCI
70
60
50
40
T1
T2
T3
T4*
T5*
T6
90
80
Bispectral index(BIS)
Diastolic Blood Pressure(mmHg)
100
T7
Data points
70
60
TCI
MCI
50
40
30
Mean Blood Pressure (mmHg)
20
140
10
130
0
T1
120
T2
T3
T4*
T5*
T6
T7
Data points
110
*Significant difference between two groups
100
TCI
MCI
90
80
70
60
50
Table 2
Duration of post anesthesia care unit (PACU) residence,
incidence of postoperative side effects and recovery
characteristics (Mean and standard deviation in parenthesis).
40
T1
T2
T3
T4*
T5*
T6
T7
Data points
* Significant difference between two groups.
In the PACU, though there were no statistical
differences between the Aldrete score between the
two groups, yet the staying time for acquiring score
of 10 was longer in the MCI group. The nausea and
vomiting incidences were higher in the MCI group and
same symptoms continued higher in the surgical ward
(Table 2).
The total consumption and rate of consumption
of Remifentanil and propofol were significantly higher
in the MCI when compared to the TCI group (Table 3).
There were no differences in the time from the
end of administration of anesthetics to eye opening
PACU
Length of stay (min)
Aldrete Scoring receiving
PACU
Nausea (n of patients)
Vomiting (n of patients)
Shivering (n of patients)
Ward
Nausea (n of Patients)
Vomiting (n of patients)
Shivering (n of patients)
*P value < 0.05 is significant
TCI
(n=30)
MCI
(n=30)
*P
value
42.54
(8)
7.2
(1.0)
6
(18%)
3 (9%)
59.01
(6)
6.4 (0.4)
0.00
0.00
9
(27%)
14
(42%)
11
(33%)
10
(30%)
10
(30%)
2 (6%)
0
17
(51%)
6 (18%)
1 (3%)
0.01
0.06
0.00
0.40
0.00
0.50
M.E.J. ANESTH 20 (6), 2010
788
N. Yeganeh et al
Table 3
Propofol and remifentanil consumed in two groups (Mean and
standard deviations in parenthesis)
*P
MCI
TCI
Value
Total Propofol administered 1178.83 872.73
0.000
(mg)
(187.86) (274.05)
Propofol used per weight and 138.81
107.84
0.007
(20.17) (25.09)
time ( µg / kg / min )
Total
remifentanil 1324.23 955.07
0.005
administered (mg)
(189.18) (285.14)
Remifentanil used per weight
0.33
0.19
0.001
(0.04)
(0.04)
and time ( µg / kg / min )
*
P value < 0.05 is significant.
Table 4
Prediction of awakening time by pump, eye opening time, obey
to commands time (extubation time) , time to reach Aldrete
score 10 and drug costs in two groups (Mean and standard
deviation in parenthesis).
*P
MCI
TCI
Value
Prediction of awakening
8.33
8.83 (2.53)
0.43
(min)
(2.92)
8.76
Eye opening time (min) 9.00 (2.24)
0.72
(2.81)
Obey to commands time
9.11
9.26 (2.19)
0.82
(min)
(2.89)
Time to reach Aldrete
59.01
42.54
0.00
score 10
(6.77)
(8.32)
35.35
(6.53)
Total cost of drugs ($)
Cost per minute ($)
0.57 (0.10)
* P value < 0.05 is significant.
29.09
(7.80)
0.45
(0.08)
0.00
0.00
(awakening time) and to extubation time (obey to
commands time) in the two groups (Table 4).
The costs of anesthetic drugs (propofol and
remifentanil) and cost of one minute of anesthesia, was
higher in the MCI than in the TCI group (0.57 ± 0.10
dollar vs 0.45 ± 0.08 dollar) (Table 4).
Materials and Methods
Following approval of the Ethics Committee of
our institution and patient written informed consent,
60 patients 18-60 years. ASA I-II scheduled for
mastoidectomy with a planned duration of what than 30
minutes, were included in the study. Exclusion criteria
consisted of patients under 18 and above 60 years, ASA
physical status more than II, hypertriglyceridemia,
alcohol or opium dependence or drug abuse and use
of beta adrenergic receptor blocking agents or α2
adrenergic receptor agonists.
All patients were unpremedicated. Patients
were randomly allocated into two groups (30 each)
by sealed envelop technique; group target controlled
infusion group (TCI) and group B or manually
controlled infusion group (MCI). On arrival to the OR
the weight of patients were measured by electronic
weighing-machine and then, electrocardiogram leads,
pulse oximetry and noninvasive blood pressure,
were attached. A 20 gauge IV cannula was inserted
in antecubital vein in all patients. Ringer solution
10 cc/kg of body weight was infused intravenously
before induction of anesthesia. Bi-refferential
electroencephalogram (EEG) leads (Aspect medical
system BIS-XP version 3.23, USA) were attached after
skin preparation and disinfection with alcohol and
slight rubbing. When electrode impedance exceeded
10 KΩ, the electrode was replaced and skin preparation
was repeated.
In (TCI) group anesthesia was induced with
propofol 1% (Braun Melsungen, Germany) and
remifentanil 50 µg/ml (GSK, UK) simultaneously
administered by two separate modules of a continuous
computer assisted TCI system (Fresenius Kabi
Company, Base Prima and DPS Module System,
France). Before induction of anesthesia, patients'
weight and height, age, sex and target of effect site
concentration of propofol and remifentanil were
entered into the TCI system. The initial effect site
target of propofol was set at 4 µg/ml, titrated against
clinical effect and BIS values, and the initial effect site
target of remifentanil was 4 ng/ml, titrated against vital
signs. We used Schnider and Minto three compartments
pharmacokinetic models for propofol and remifentanil
respectively (5-6). The goal of propofol administration
was to maintain BIS level from 45 to 60.
After hypnosis (lack of eyelid reflex), atracurium
(0.5 mg/kg) was administered IV slowly to achieve
muscle relaxation for endotracheal intubation. The
atracurium dose was repeated to maintain post tetanic
count zero. After intubation the effect site concentration
of propofol and remifentanil were adjusted to maintain
the BIS level from 45 to 60 and 55 < MAP > 85
mmHg. BIS values beyond the desired levels were
managed with increasing or decreasing 1 µg/ml from
propofol effect site target concentration, and MAP far
from desired levels also managed with increasing or
TARGET-CONTROLLED INFUSION ANESTHESIA WITH PROPOFOL AND REMIFENTANIL COMPARED WITH
MANUALLY CONTROLLED INFUSION ANESTHESIA IN MASTOIDECTOMY SURGERIES
Fig. 4
Satisfaction of surgeons about surgical field.
* In good condition difference between two groups is significant.
decreasing 0.5 ng/ml to effect site target concentration
of remifentanil (Flowchart1).
With decreasing of MAP < 55 mmHg, crystalloids
(Ringer solution) were infused and until a clinically
adequate volume load was achieved a vasopressor
789
(Ephedrine) 2.5 mg i.v was administered to restore
MAP immediately. With increasing MAP > 85 mmHg
increasing the effect site concentration of remifentanil
was repeated step by step until reaching remifentanil
target to 10 ng/ml and if this failed to reduce MAP <
85 mmHg, infusion of trinitroglycerine 5 µg/min was
added.
In the MCI group anesthesia was induced with
bolus propofol infusion 1 mg/kg and after that 170 µg/
kg/min for 10 minutes, and then 130 µg/kg/min for 10
minutes and finally 100 µg/kg/min for maintenance of
anesthesia. This method of propofol infusion produces
and maintains propofol plasmatic concentration about
4 µg/ml7. Remifentanil infusion was started with
Flowchart 1
Anesthetics administration algorithm in TCI group
M.E.J. ANESTH 20 (6), 2010
790
N. Yeganeh et al
Flowchart 2
Anesthetics administration algorithm in MCI group
slow bolus dose of 1 µg/kg and then was continued
0.5 µg/kg/min. After loss of consciousness atracurium
was administered, repeated and managed as the same
manner as in TCI group. The goals of anesthesia were
the same as in TCI group. BIS values and MAP out
of the desired range was managed with increasing
or decreasing of propofol and remifentanil infusion
rate 10 µg/kg/min and 0.25 µg/kg/min respectively
(Flowchart 2).
In both groups patients were ventilated to
maintain normocapnia (ETCO2 between 36-44 mmHg
with mixture of oxygen in air (FIO2 40%). In all patients
the continuous infusion of propofol and remifentanil
were stopped at the beginning of skin closure when 2
mg morphine sulphate and 4 mg ondansetrone were
administered intravenously for postoperative analgesia
and prophylaxia of nausea and vomiting.
The time from stopping the infusion until
patients opened their eyes (eye opening time), obeyed
to commands and underwent tracheal extubation
(extubation time) and the time from stopping the
infusion until Aldrete score of 10 were documented and
compared in two the groups8. Six different surgeons
blinded to anesthesia method conducted were asked
TARGET-CONTROLLED INFUSION ANESTHESIA WITH PROPOFOL AND REMIFENTANIL COMPARED WITH
MANUALLY CONTROLLED INFUSION ANESTHESIA IN MASTOIDECTOMY SURGERIES
about their satisfaction about asanguineous surgical
field which was described as good (without disturbing
bleeding), moderate (minimal bleeding not disturbing
surgery) and poor (bleeding disturbing surgery).
Seven data points were defined for monitoring
and documentation of vital signs and BIS: T1, before
the induction of anesthesia; T2, before intubation;
T3, three minutes after tracheal intubation; T4, three
minutes after skin incision; T5, during mastoidectomy;
T6, during tympanic membrane placement and T7,
before skin closure.
The costs of intravenous anesthetic drugs
(disposables, nursing, staff, oxygen, air, vasopressors
and antiemetics were not included) were taken from
hospital pharmacy list.
Data were presented as mean with standard
deviation in parenthesis unless otherwise stated. For
statistical analysis SPSS software (version 11.5)
was used. Hemodynamic variables were analyzed
with two factorial analysis of variance for repeated
measurements. Student's t-test was applied at the
end point of each measurement. In case of multiple
comparisons, P values were corrected according to
Bonferroni. Fisher's exact tests, X² tests, leven tests,
Mann-Whitney U-tests, or nonpaired student's t-tests
were used when appropriate. P values < 0.05 were
considered significant.
Discussion
In this study we used propofol as hypnotic
together with remifentanil as analgesic for induction
and maintenance of anesthesia. Propofol is presently
the most common intravenous anesthetic used for total
intravenous anesthesia. Pharmacokinetic model-driven
infusion of propofol has become widely available
worldwide. In addition, remifentanil is the newest
μ-agonist available for administration as an analgesic
during surgery and it is best administered as an infusion
because of its metabolism by general body esterases.
Interaction of these two drugs in preventing
responses to noxious stimulation is investigated.
Increasing the duration of the infusion has minimal
impact on recovery time if the optimal dose of
remifentanil is not used9. Hence combination of these
two drugs has become more popular for intravenous
791
anesthesia. Regardless of the kind of surgery,
remifentanil improves intraoperative hemodynamic
stability when compared to other opioids: Twersky
reported better hemodynamic control when remifentanil
used compared with fentanyl10 and Mackey confirmed
better control of tachycardia and hypertension in very
high risk outpatients laryngoscopies with remifentanil
as compared to fentanyl11. In our study remifentanil was
used as an analgesic in both TCI and MCI, however,
the TCI group when surgical stimuli were profound
showed more stable hemodynamic parameters in
different data points at T4 (three minutes after skin
incision) and T5 (during mastoidectomy). This is
very important in mastoidectomy operations because
bleeding in surgical field is directly related to blood
pressure and even when minimal bleeding may disturb
the ideal condition for surgery.
Remifentanil is associated with faster recovery
and extubation time because of its rapid hydrolysis
and decreased hypnotic requirements. This can affect
early and late recovery and discharge time of patients
from operating table to the (PACU) and eventually to
surgical wards and finally to home. Remifentanil as an
anesthetic used as TCI method has showed superiority
to the conventional manually controlled infusion
(MCI).
Various studies have shown that hemodynamic
stability, recovery time, and discharge time have
improved by the use of TCI for the administration
of remifentanil and propofol in the induction and
maintenance of anesthesia12-13. Despite these findings
other authors could not show significant hemodynamic
differences between TCI and MCI group during
induction and maintenance of anesthesia14-15.
We think the findings in our study are the result
of administration both hypnotic and analgesic with
TCI technique which allows fine titration of effectsite target concentration counter effecting the noxious
stimuli. The TCI enables anesthesiologist to rapidly
change the effect-site target concentration of desired
drug for desired response without need to timeoccupying mathematical calculation to adjust infusion
rate for body mass of the patient. Also our findings
demonstrated the efficacy of TCI in controlling
anesthesia depth during different stages of surgery
as well as MCI. Although all patients were received
M.E.J. ANESTH 20 (6), 2010
792
to PACU with comparable Aldrete score, the MCI
patients, however, stayed more in this unit to reach
Aldrete score 10. In other word, intermediate recovery
time (discharge from PACU to surgical ward) was
longer in the MCI group. This correlates with total
propofol and remifentanil consumed during anesthesia
observed more in the MCI group.
Although we found less drug consummation and
decreased drug cost in the TCI group, literature review
is contradictory, Suttner found that TCI using propofol
and remifentanil was the most expensive anesthesia
regimen, with total intraoperative costs almost two
fold compared with the standard IV propofol regimen
and almost four times larger compared with a standard
inhaled anesthetic with isoflurane in sixty patients
undergoing elective laparoscopic cholecystectomies12.
Fombeur and coworkers described a standard regimen
of desflurane was more cost-effective than TCI
propofol for anesthesia maintenance in achieving
post operative nausea and vomiting free episodes in
otlogical surgeries16 Russell and coworkers17 found
significantly more propofol was administered during
both induction and maintenance of anesthesia with the
target controlled system while no clinically significant
difference in heart rate and hemodynamic variables
were observed. On the other hand De castro and
coworkers reported significantly smaller requirements
of remifentanil without a difference in propofol
requirement and at the same time more common
intraoperative hypotension episodes in MCI group
patients than TCI group18.
Limitation of our study lies in the fact that our
data collection was not performed continuously in
all times of the operation but in selected data points
in which hemodynamic imbalance episodes were
more probable. Despite this limitation data in the
N. Yeganeh et al
postoperative time were collected continuously in
which the PONV and the shorter staying time in
recovery room to reach Aldrete score of 10 the TCI
group.
The possible explanations can explain the
contradictory results with the tel system, consiste
that studies used only hypnotic or analgesic and in
others both been administered by TCI. Fine titration
of hypnotic and/or analgesic target concentration
against clinical effects can rapidly produce desired
clinical situation without time delay and uncontrolled
hemodynamic changes. Changing effect-site target
concentration of every drug and attention to drug
pharmacodynamic instead of drug pharmacokinetic
can result to more stable hemodynamic variables, less
drug consumption and shorter recovery time19. On the
other hand biovariabilty plays an important role in
different responses to identical target concentration
in various studies20. Several models have been
proposed and validated for their ability to predict drug
concentration in the plasma or effect site compartment
for propofol and remifentanil. Biovariability and
severeal pharmacokinetic models produces different
results when TCI is used. In summary remifentanilpropofol TCI-based anesthesia achieved better
hemodynamic stability through the stages, better
recovery profile, decreases drug costs of anesthetics
and more satisfaction of surgeons about surgical field
condition, as compared to the manually controlled
infusion (MCI) anesthesia, in mastoidectomy surgeries.
Acknowledgement
We would like to thank the research authorities
of Kermanshah University of Medical Sciences and
Health Services for funding this study.
TARGET-CONTROLLED INFUSION ANESTHESIA WITH PROPOFOL AND REMIFENTANIL COMPARED WITH
MANUALLY CONTROLLED INFUSION ANESTHESIA IN MASTOIDECTOMY SURGERIES
793
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